Trial · NCT01302080

Sertraline Pediatric Registry for the Evaluation of Safety (SPRITES)

NCT01302080, Completed, Pfizer's Upjohn has merged with Mylan to form Viatris Inc.; results first posted 2021-10-08

3 sourcestrials-2026-11-12-0.5.0

Cite this record

ConductScience Library. Sertraline Pediatric Registry for the Evaluation of Safety (SPRITES). Trials, record NCT01302080. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01302080

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Trial

As registered on ClinicalTrials.gov, in the graph's capture of the registry.

Title: Sertraline Pediatric Registry for the Evaluation of Safety (SPRITES)
NCT number: NCT01302080
Status: Completed
Enrollment: 941 participants, actual
Lead sponsor: Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
Conditions: Obsessive Compulsive Disorder
Interventions: sertraline, psychotherapy
First posted: 2011-02-23
Last updated: 2021-10-14
Results first posted: 2021-10-08

Source ClinicalTrials.gov

Registered outcomes64

Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.

List	Outcome	Time frame	Description
Primary	Change From Baseline in Cognitive Function Using Trails B at Month 3	Baseline, Month 3	Trail B test is a set of shifting task, in which participants were asked to drawn a line from number 1 to letter A, then to number 2, then to letter B, then to number 3, then to letter C then so forth until they connected the circles as quickly as possible, without lifting pen or pencil from the paper. Participant was timed (maximum time limit was 300 seconds or 5 minutes) to connect the "trail." If the participant made an error, and it was pointed out immediately, the participant was allowed to correct it. Errors affected the participant's score only in that the correction of errors was included in the completion time for the task. A higher number of errors was indicative of a higher cognitive deficit. Raw results were the number of seconds required to complete the task; therefore, higher scores reveal greater impairment. Raw results based on age norms were transformed to Z-scores. Z-score = actual value minus normative value divided by standard deviation.
Primary	Change From Baseline in Cognitive Function Using Trails B at Month 6	Baseline, Month 6	Trail B test is a set of shifting task, in which participants were asked to drawn a line from number 1 to letter A, then to number 2, then to letter B, then to number 3, then to letter C then so forth until they connected the circles as quickly as possible, without lifting pen or pencil from the paper. Participant was timed (maximum time limit was 300 seconds or 5 minutes) to connect the "trail." If the participant made an error, and it was pointed out immediately, the participant was allowed to correct it. Errors affected the participant's score only in that the correction of errors was included in the completion time for the task. A higher number of errors was indicative of a higher cognitive deficit. Raw results were the number of seconds required to complete the task; therefore, higher scores reveal greater impairment. Raw results based on age norms were transformed to Z-scores. Z-score = actual value minus normative value divided by standard deviation.
Primary	Change From Baseline in Cognitive Function Using Trails B at Month 12	Baseline, Month 12	Trail B test is a set of shifting task, in which participants were asked to drawn a line from number 1 to letter A, then to number 2, then to letter B, then to number 3, then to letter C then so forth until they connected the circles as quickly as possible, without lifting pen or pencil from the paper. Participant was timed (maximum time limit was 300 seconds or 5 minutes) to connect the "trail." If the participant made an error, and it was pointed out immediately, the participant was allowed to correct it. Errors affected the participant's score only in that the correction of errors was included in the completion time for the task. A higher number of errors was indicative of a higher cognitive deficit. Raw results were the number of seconds required to complete the task; therefore, higher scores reveal greater impairment. Raw results based on age norms were transformed to Z-scores. Z-score = actual value minus normative value divided by standard deviation.
Primary	Change From Baseline in Cognitive Function Using Trails B at Month 18	Baseline, Month 18	Trail B test is a set of shifting task, in which participants were asked to drawn a line from number 1 to letter A, then to number 2, then to letter B, then to number 3, then to letter C then so forth until they connected the circles as quickly as possible, without lifting pen or pencil from the paper. Participant was timed (maximum time limit was 300 seconds or 5 minutes) to connect the "trail." If the participant made an error, and it was pointed out immediately, the participant was allowed to correct it. Errors affected the participant's score only in that the correction of errors was included in the completion time for the task. A higher number of errors was indicative of a higher cognitive deficit. Raw results were the number of seconds required to complete the task; therefore, higher scores reveal greater impairment. Raw results based on age norms were transformed to Z-scores. Z-score = actual value minus normative value divided by standard deviation.
Primary	Change From Baseline in Cognitive Function Using Trails B at Month 24	Baseline, Month 24	Trail B test is a set of shifting task, in which participants were asked to drawn a line from number 1 to letter A, then to number 2, then to letter B, then to number 3, then to letter C then so forth until they connected the circles as quickly as possible, without lifting pen or pencil from the paper. Participant was timed (maximum time limit was 300 seconds or 5 minutes) to connect the "trail." If the participant made an error, and it was pointed out immediately, the participant was allowed to correct it. Errors affected the participant's score only in that the correction of errors was included in the completion time for the task. A higher number of errors was indicative of a higher cognitive deficit. Raw results were the number of seconds required to complete the task; therefore, higher scores reveal greater impairment. Raw results based on age norms were transformed to Z-scores. Z-score = actual value minus normative value divided by standard deviation.
Primary	Change From Baseline in Cognitive Function Using Trails B at Month 30	Baseline, Month 30	Trail B test is a set of shifting task, in which participants were asked to drawn a line from number 1 to letter A, then to number 2, then to letter B, then to number 3, then to letter C then so forth until they connected the circles as quickly as possible, without lifting pen or pencil from the paper. Participant was timed (maximum time limit was 300 seconds or 5 minutes) to connect the "trail." If the participant made an error, and it was pointed out immediately, the participant was allowed to correct it. Errors affected the participant's score only in that the correction of errors was included in the completion time for the task. A higher number of errors was indicative of a higher cognitive deficit. Raw results were the number of seconds required to complete the task; therefore, higher scores reveal greater impairment. Raw results based on age norms were transformed to Z-scores. Z-score = actual value minus normative value divided by standard deviation.
Primary	Change From Baseline in Cognitive Function Using Trails B at Month 36	Baseline, Month 36	Trail B test is a set of shifting task, in which participants were asked to drawn a line from number 1 to letter A, then to number 2, then to letter B, then to number 3, then to letter C then so forth until they connected the circles as quickly as possible, without lifting pen or pencil from the paper. Participant was timed (maximum time limit was 300 seconds or 5 minutes) to connect the "trail." If the participant made an error, and it was pointed out immediately, the participant was allowed to correct it. Errors affected the participant's score only in that the correction of errors was included in the completion time for the task. A higher number of errors was indicative of a higher cognitive deficit. Raw results were the number of seconds required to complete the task; therefore, higher scores reveal greater impairment. Raw results based on age norms were transformed to Z-scores. Z-score = actual value minus normative value divided by standard deviation.
Primary	Change From Baseline in Cognitive Function Using Metacognition Index From Behavior Rating Inventory of Executive Function (BRIEF) at Month 3	Baseline, Month 3	BRIEF has 86-items to measure the neurocognitive performance for 8 subscales: inhibit, shift, emotional control, initiate, working memory, plan-organize, organization of materials and monitor. These are subsumed in 2 broad factors: a behavior regulation index consisted inhibit, shift, and emotional control subscales, a metacognition index consisted working memory, initiate, plan/organize, organization of materials, and task-monitor scale. Each item had a 3-point scale (1= never, 2= sometimes, 3= often). Z-score was based on mean raw score for T-score= 50 and SD = +/- 10. (actual value raw score at T=50)/SD (mean SD where T=40,60), based on age and gender norms from BRIEF professional manual. T-score provided information of individual's scores relative to scores of respondents in the standardization sample. Lower Z- scores indicated better functioning.
Primary	Change From Baseline in Cognitive Function Using Metacognition Index From Behavior Rating Inventory of Executive Function (BRIEF) at Month 6	Baseline, Month 6	BRIEF has 86-items to measure the neurocognitive performance for 8 subscales: inhibit, shift, emotional control, initiate, working memory, plan-organize, organization of materials and monitor. These are subsumed in 2 broad factors: a behavior regulation index consisted inhibit, shift, and emotional control subscales, a metacognition index consisted working memory, initiate, plan/organize, organization of materials, and task-monitor scale. Each item had a 3-point scale (1= never, 2= sometimes, 3= often). Z-score was based on mean raw score for T-score= 50 and SD = +/- 10. (actual value raw score at T=50)/SD (mean SD where T=40,60), based on age and gender norms from BRIEF professional manual. T-score provided information of individual's scores relative to scores of respondents in the standardization sample. Lower Z- scores indicated better functioning.
Primary	Change From Baseline in Cognitive Function Using Metacognition Index From Behavior Rating Inventory of Executive Function (BRIEF) at Month 12	Baseline, Month 12	BRIEF has 86-items to measure the neurocognitive performance for 8 subscales: inhibit, shift, emotional control, initiate, working memory, plan-organize, organization of materials and monitor. These are subsumed in 2 broad factors: a behavior regulation index consisted inhibit, shift, and emotional control subscales, a metacognition index consisted working memory, initiate, plan/organize, organization of materials, and task-monitor scale. Each item had a 3-point scale (1= never, 2= sometimes, 3= often). Z-score was based on mean raw score for T-score= 50 and SD = +/- 10. (actual value raw score at T=50)/SD (mean SD where T=40,60), based on age and gender norms from BRIEF professional manual. T-score provided information of individual's scores relative to scores of respondents in the standardization sample. Lower Z- scores indicated better functioning.

1 to 10 of 64Source ClinicalTrials.gov

See all 64 registered outcomes

Outcomes64

Each outcome the trial posted results for, in ClinicalTrials.gov's words.

Type	Outcome	Time frame	Population	Units	Measured as
PRIMARY	Change From Baseline in Cognitive Function Using Trails B at Month 3	Baseline, Month 3	Analysis population included all participants in the database who had informed consent. Here, Overall Number of Participants Analyzed signifies number of participants evaluable for this outcome measure and Number Analyzed signifies number of participants evaluable at specified time points.	Z-score	MEAN
PRIMARY	Change From Baseline in Cognitive Function Using Trails B at Month 6	Baseline, Month 6	Analysis population included all participants in the database who had informed consent. Here, Overall Number of Participants Analyzed signifies number of participants evaluable for this outcome measure.	Z-score	MEAN
PRIMARY	Change From Baseline in Cognitive Function Using Trails B at Month 12	Baseline, Month 12	Analysis population included all participants in the database who had informed consent. Here, Overall Number of Participants Analyzed signifies number of participants evaluable for this outcome measure.	Z-score	MEAN
PRIMARY	Change From Baseline in Cognitive Function Using Trails B at Month 18	Baseline, Month 18	Analysis population included all participants in the database who had informed consent. Here, Overall Number of Participants Analyzed signifies number of participants evaluable for this outcome measure.	Z-score	MEAN
PRIMARY	Change From Baseline in Cognitive Function Using Trails B at Month 24	Baseline, Month 24	Analysis population included all participants in the database who had informed consent. Here, Overall Number of Participants Analyzed signifies number of participants evaluable for this outcome measure.	Z-score	MEAN
PRIMARY	Change From Baseline in Cognitive Function Using Trails B at Month 30	Baseline, Month 30	Analysis population included all participants in the database who had informed consent. Here, Overall Number of Participants Analyzed signifies number of participants evaluable for this outcome measure.	Z-score	MEAN
PRIMARY	Change From Baseline in Cognitive Function Using Trails B at Month 36	Baseline, Month 36	Analysis population included all participants in the database who had informed consent. Here, Overall Number of Participants Analyzed signifies number of participants evaluable for this outcome measure.	Z-score	MEAN
PRIMARY	Change From Baseline in Cognitive Function Using Metacognition Index From Behavior Rating Inventory of Executive Function (BRIEF) at Month 3	Baseline, Month 3	Analysis population included all participants in the database who had informed consent. Here, Overall Number of Participants Analyzed signifies number of participants evaluable for this outcome measure and Number Analyzed signifies number of participants evaluable at specified time points.	Z-score	MEAN
PRIMARY	Change From Baseline in Cognitive Function Using Metacognition Index From Behavior Rating Inventory of Executive Function (BRIEF) at Month 6	Baseline, Month 6	Analysis population included all participants in the database who had informed consent. Here, Overall Number of Participants Analyzed signifies number of participants evaluable for this outcome measure.	Z-score	MEAN
PRIMARY	Change From Baseline in Cognitive Function Using Metacognition Index From Behavior Rating Inventory of Executive Function (BRIEF) at Month 12	Baseline, Month 12	Analysis population included all participants in the database who had informed consent. Here, Overall Number of Participants Analyzed signifies number of participants evaluable for this outcome measure.	Z-score	MEAN

1 to 10 of 64Source ClinicalTrials.gov

See all 64 outcomes

Results by group910

Each measurement the trial posted, group by group, in the words and numbers it posted.

Outcome	Group	Category	Value	Spread	Units
Change From Baseline in Cognitive Function Using Trails B at Month 3	Sertraline	Baseline	1.03	Standard Deviation 2.3	Z-score
Change From Baseline in Cognitive Function Using Trails B at Month 3	Other Antidepressants	Baseline	1.23	Standard Deviation 1.0	Z-score
Change From Baseline in Cognitive Function Using Trails B at Month 3	Psychotherapy	Baseline	0.61	Standard Deviation 1.8	Z-score
Change From Baseline in Cognitive Function Using Trails B at Month 3	Sertraline	Change at Week 3	-0.39	Standard Deviation 1.6	Z-score
Change From Baseline in Cognitive Function Using Trails B at Month 3	Other Antidepressants	Change at Week 3	-0.09	Standard Deviation 0.5	Z-score
Change From Baseline in Cognitive Function Using Trails B at Month 3	Psychotherapy	Change at Week 3	-0.03	Standard Deviation 2.3	Z-score
Change From Baseline in Cognitive Function Using Trails B at Month 6	Sertraline		-0.64	Standard Deviation 2.2	Z-score
Change From Baseline in Cognitive Function Using Trails B at Month 6	Other Antidepressants		-0.65	Standard Deviation 1.0	Z-score
Change From Baseline in Cognitive Function Using Trails B at Month 6	Psychotherapy		-0.16	Standard Deviation 1.9	Z-score
Change From Baseline in Cognitive Function Using Trails B at Month 12	Sertraline		-0.72	Standard Deviation 2.3	Z-score

1 to 10 of 910Source ClinicalTrials.gov

See all 910 results by group

Participant flow6

How many started, completed or left each group, period by period.

Period	Milestone	Group	Participants
Overall Study	STARTED	Sertraline	696
Overall Study	STARTED	Psychotherapy	245
Overall Study	COMPLETED	Sertraline	330
Overall Study	COMPLETED	Psychotherapy	102
Overall Study	NOT COMPLETED	Sertraline	366
Overall Study	NOT COMPLETED	Psychotherapy	143

Source ClinicalTrials.gov

Adverse events5,184

Each adverse event the trial posted, group by group: the participants affected out of those at risk.

Type	Event	Organ system	Group	Affected	At risk
other	Abdominal pain	Gastrointestinal disorders	Sertraline (Baseline)	0	614
other	Abdominal pain	Gastrointestinal disorders	Other Antidepressants (Baseline)	0	3
other	Abdominal pain	Gastrointestinal disorders	Psychotherapy (Baseline)	1	181
other	Abdominal pain	Gastrointestinal disorders	Sertraline (Month 3)	9	622
other	Abdominal pain	Gastrointestinal disorders	Other Antidepressants (Month 3)	0	19
other	Abdominal pain	Gastrointestinal disorders	Psychotherapy (Month 3)	3	384
other	Abdominal pain	Gastrointestinal disorders	Sertraline (Month 6)	11	516
other	Abdominal pain	Gastrointestinal disorders	Other Antidepressants (Month 6)	1	48
other	Abdominal pain	Gastrointestinal disorders	Psychotherapy (Month 6)	5	181
other	Abdominal pain	Gastrointestinal disorders	Sertraline (Month 12)	5	426

1 to 10 of 5,184Source ClinicalTrials.gov

See all 5,184 adverse events

Adverse event totals72

The totals the trial posted for each group.

Total	Group	At risk
Total, all-cause mortality	Sertraline (Baseline)	614
Total, all-cause mortality	Other Antidepressants (Baseline)	3
Total, all-cause mortality	Psychotherapy (Baseline)	181
Total, all-cause mortality	Sertraline (Month 3)	622
Total, all-cause mortality	Other Antidepressants (Month 3)	19
Total, all-cause mortality	Psychotherapy (Month 3)	384
Total, all-cause mortality	Sertraline (Month 6)	516
Total, all-cause mortality	Other Antidepressants (Month 6)	48
Total, all-cause mortality	Psychotherapy (Month 6)	181
Total, all-cause mortality	Sertraline (Month 12)	426

1 to 10 of 72Source ClinicalTrials.gov

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Papers2

The papers the trial lists on ClinicalTrials.gov.

PMID	Listed as	Source
34287023	DERIVED	PubMed
36799958	DERIVED	PubMed

Grants0

The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.

None in this release.

Trial comparisons0

Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.

None in this release.

Tests1

The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.

Test	Named as
Trail Making Test B	Primary outcome

Source ConductCognition

Data dates

The day each source was copied for this release.

ClinicalTrials.gov: 2026-11-12; ClinicalTrials.gov
Results, from AACT: 2026-03-23; AACT
NIH grant links: 2026-11-13; NIH RePORTER

Sources 3

ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
ClinicalTrials.govNo license stated
NIH RePORTER's clinical studies and project filesPublic domain

Each source's terms

ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
ClinicalTrials.govnone stated
NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)

ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.

For software

Read this trial from software.

The record and each of its lists are JSON, twenty rows a page. No key.

GET https://conductscience.org/api/trials/v1/NCT01302080

GET https://conductscience.org/api/trials/v1/NCT01302080/registered?page=2

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